Zenas BioPharma, Inc.

Zenas BioPharma, Inc. announced that its Compensation Committee granted 100,000 non-qualified stock options and 78,075 restricted stock units (RSUs) to newly hired employees on June 15, 2026. These inducement grants, made under Nasdaq Listing Rule 5635(c)(4), are intended to attract new talent. The stock options have a ten-year term with an exercise price of $18.71 and vest over four years, while the RSUs also vest in four equal installments over a four-year period.

Zenas BioPharma, a clinical-stage biopharmaceutical company specializing in autoimmune diseases, announced that its management will present at the H.C. Wainwright 7th Annual Neuro Perspectives Expert Summit. The presentation will be available on-demand starting June 15, 2026, at 7:00 a.m. ET, with a webcast and replay accessible on the company's investor relations website. Zenas is currently advancing late-stage molecules obexelimab and orelabrutinib, alongside earlier stage programs ZB021, ZB022, and ZB014.

Zenas BioPharma announced positive Phase 3 INDIGO trial results for obexelimab in Immunoglobulin G4-Related Disease (IgG4-RD), meeting its primary and all key secondary endpoints with statistical significance. The data, presented at EULAR 2026 and published in the New England Journal of Medicine, showed obexelimab significantly reduced disease flares, glucocorticoid use, and related toxicities, with a favorable safety profile. The company submitted a Biologics License Application (BLA) to the FDA in May for obexelimab in IgG4-RD. Zenas also anticipates topline results from its Phase 2 SunStone SLE trial later this year.

Zenas BioPharma announced the submission of its Biologics License Application (BLA) to the U.S. Food and Drug Administration for obexelimab, an investigational therapy for Immunoglobulin G4-Related Disease (IgG4-RD). This submission is based on positive results from the Phase 3 INDIGO trial, where obexelimab significantly reduced the risk of IgG4-RD flare by 56% compared to placebo and met all key secondary endpoints. The company believes obexelimab could serve as a first-line therapy for long-term management of IgG4-RD, with data to be presented at the EULAR 2026 Congress. Zenas also expects to report topline results from a Phase 2 trial for Systemic Lupus Erythematosus in Q4 2026.

Zenas BioPharma announced positive safety and efficacy results from its Phase 3 INDIGO trial for obexelimab in Immunoglobulin G4-Related Disease (IgG4-RD). The trial met its primary endpoint, showing a highly statistically significant 56% reduction in IgG4-RD flare risk compared to placebo. Obexelimab also met all four key secondary endpoints and was well tolerated with no new safety signals. These results will be presented at the EULAR 2026 Congress on June 4, 2026. The company also expects topline results from a Phase 2 trial for Systemic Lupus Erythematosus in Q4 2026.

Zenas BioPharma, Inc. announced that its Compensation Committee granted an aggregate of 51,075 restricted stock units (RSUs) to newly hired employees on May 15, 2026. These grants serve as an inducement for their employment, in accordance with Nasdaq Listing Rule 5635(c)(4). The RSUs will vest in four equal installments over a four-year period, contingent on the employees' continued service, with the first vesting occurring on May 15, 2027.

Zenas BioPharma announced the dosing of the first subject in its Phase 1 trial for ZB021, a novel potentially best-in-class oral IL-17AA/AF inhibitor. The trial will evaluate the safety, tolerability, and pharmacokinetic properties of ZB021 in healthy volunteers, with proof-of-concept in patients with plaque psoriasis. Single and multiple ascending dose data are expected by year-end 2026, and proof-of-concept data in psoriasis patients are anticipated in 2027. Zenas believes the established IL-17 mechanism may support an accelerated path toward registration-directed trials.

Zenas BioPharma reported a net loss of $(80.99) million for the first quarter of 2026, a significant increase from $(33.57) million in the same period last year, with no revenue generated. Despite the increased losses and R&D expenses, the company substantially strengthened its liquidity position by raising $433.48 million through a senior secured term loan, convertible senior notes, and equity offerings. This financing is expected to fund operations and capital expenditures for at least the next twelve months.

Zenas BioPharma reported a Q1 2026 net loss of $81.0 million, an increase from $33.6 million in Q1 2025, primarily due to increased R&D and G&A expenses. The company significantly strengthened its balance sheet by raising $419.0 million in gross proceeds year-to-date through public offerings and a debt facility, extending its cash runway into Q2 2029. Key pipeline advancements include obexelimab marketing applications for IgG4-RD on track for FDA submission this quarter and EMA in H2 2026, and enrollment completion for the Phase 2 SunStone SLE trial with topline results expected in Q4 2026. Additionally, the first subject was dosed in the Phase 1 trial for ZB021, and Director Tomas Kiselak resigned from the Board.

Zenas BioPharma reported Q1 2026 financial results and provided corporate updates, highlighting significant progress in its clinical pipeline and a strengthened balance sheet. The company expects to submit Obexelimab marketing applications for IgG4-RD to the FDA this quarter and the EMA in H2 2026, with Phase 3 INDIGO trial results accepted for oral presentation at EULAR 2026. Enrollment for the Phase 2 SunStone SLE trial is complete, with topline results anticipated in Q4 2026. Zenas also completed public offerings and debt financing, raising $419.0 million, extending its cash runway into Q2 2029. The net loss for Q1 2026 increased to $81.0 million from $33.6 million in Q1 2025, primarily due to increased R&D and G&A expenses.